Research Associate, Analytical Ops

Descripción del trabajo

Specific Job Responsibilities:

• Conduct GMP testing for release, stability, and method transfer for clinical drug substances and products.

• Conduct GMP testing for raw materials, raw material intermediates, in-process control, and cleaning samples in support of pilot plant manufacturing

• Analyze samples using various analytical techniques such as Ultra-Performance Liquid Chromatography/High-Performance Liquid Chromatography (UPLC/HPLC), Gas Chromatography, Ion Chromatography, Dissolution, Karl Fischer, Differential Scanning Calorimetry, Particle Size Distribution, X-Ray Powder Diffraction, UV-Vis spectroscopy, etc.

• Perform verification and data review to ensure compliance to appropriate Standard Operating Procedures (SOPs), test methods, specifications, and protocols

• Perform stability data trending, conduct laboratory investigations for suspect results, and troubleshoot instruments and test methods

• Author/Review laboratory investigation records (issues and investigations), deviations, and Corrective and Preventive Action (CAPA)

• Provide on-the-job training of analytical techniques or other Good Manufacturing Practice (GMP) training to new hires or junior staff

• Write/Revise protocols, methods, SOPs, reports, etc.

• Participate in laboratory housekeeping activities and report any concerns to a laboratory lead and/or manager

• Lead projects and support cross-functional activities (e.g., instrument/system upgrade activities, method validation, etc.)

• Serve as a Subject Matter Expert in analytical techniques or processes, participate in working groups, assess pharmacopeial changes, and support internal audits and regulatory inspections, as appropriate

Specific Education & Experience Requirements:
BA or BS in Chemistry or Biology with 0+ years industry experience.